Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 2dc5ddfb-f2e8-43ef-8900-836e50068b75
Route
TOPICAL
Published
Effective Date 2016-03-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (3 g) Homosalate (10 g) Octisalate (5 g) Octocrylene
Inactive Ingredients
Water Ethylhexyl Palmitate Propylene Glycol Benzyl Alcohol Chlorphenesin Glyceryl Monostearate Peg-100 Stearate Sodium Hydroxide Edetate Disodium Tocopherol Diethylhexyl Syringylidenemalonate Aloe Vera Leaf Sodium Ascorbyl Phosphate Medium-chain Triglycerides

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2016-03-03
Description

Avobenzone 3.0%, Homosalate 10.0%, Octisalate 5.0%, Octocrylene 10.0%

Purpose

Sunscreen

Medication Information

Purpose

Sunscreen

Description

Avobenzone 3.0%, Homosalate 10.0%, Octisalate 5.0%, Octocrylene 10.0%

Uses
  • helps prevent sunburn
  • if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun
Warnings

For external use only

Directions
  • apply liberally 15 minutes before sun exposure
  • reapply:
  • after 80 minutes of swimming or sweating
  • immediately after towel drying
  • at least every 2 hours
  • Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging.  To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other protection measures including:
  • limit time in the sun, especially from 10 a.m. to 2 p.m.
  • wear long-sleeved shirts, pants, hats, and sunglasses
  • children under 6 months: Ask a doctor

Do Not Use

on damaged or broken skin

Other Information
  • protect this product from excessive heat and direct sun

Active Ingredients

Avobenzone 3.0%, Homosalate 10.0%, Octisalate 5.0%, Octocrylene 10.0%

Inactive Ingredients

Water, Ethylhexyl Palmitate, Polyglyceryl-3 Methylglucose Distearate, Propylene Glycol, Acrylates/C12-22 Alkyl Methacrylate, Copolymer, Benzyl Alcohol, Chlorphenesin, Acrylates/ C10-30 Alkyl Acrylate Crosspolymer, Glyceryl Stearate, PEG-100 Stearate, Sodium Hydroxide, Disodium EDTA, Fragrance, Tocopherol, Diethylhexyl Syringylidenemalonate, Aloe Barbadensis Leaf Juice Powder, Sodium Ascorbyl Phosphate, Caprylic/Capric Triglyceride

Principle Display Label

11822-9202-2

daylogic

sunscreen

LOTION

BROAD SPECTRUM SPF 30

UVA/UVB Protection

Water Resistant (80 Minutes)

Vitamin E and Aloe

RECOMMNEDED SKIN CANCER FOUNDATION

ACTIVE

RECOMMENDED AS EFFECTIVE UVA/UVB SUNSCREEN

30

8 FL OZ (236mL)







11822-9202-6

daylogic

sunscreen

LOTION



BROAD SPECTRUM SPF 30

UVA/UVB Protection

Water Resistant (80 Minutes)

Vitamin E and Aloe

RECOMMENDED SKIN CANCER FOUNDATION

ACTIVE

RECOMMENDED AS EFFECTIVE UVA/UVB SUNSCREEN

30

8 FL OZ (236mL)

When Using This Product

keep out of eyes.  Rinse with water to remove.

Stop Use and Ask A Doctor

if rash occurs

Keep Out of Reach of Children.


If product is swallowed, get medical help or contact a Poison Control Center right away.



  • May stain some fabrics

Structured Label Content

Uses
  • helps prevent sunburn
  • if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun
Purpose

Sunscreen

Warnings

For external use only

Directions
  • apply liberally 15 minutes before sun exposure
  • reapply:
  • after 80 minutes of swimming or sweating
  • immediately after towel drying
  • at least every 2 hours
  • Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging.  To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other protection measures including:
  • limit time in the sun, especially from 10 a.m. to 2 p.m.
  • wear long-sleeved shirts, pants, hats, and sunglasses
  • children under 6 months: Ask a doctor

Do Not Use (Do not use)

on damaged or broken skin

Other Information (Other information)
  • protect this product from excessive heat and direct sun

Active Ingredients (Active ingredients)

Avobenzone 3.0%, Homosalate 10.0%, Octisalate 5.0%, Octocrylene 10.0%

Inactive Ingredients

Water, Ethylhexyl Palmitate, Polyglyceryl-3 Methylglucose Distearate, Propylene Glycol, Acrylates/C12-22 Alkyl Methacrylate, Copolymer, Benzyl Alcohol, Chlorphenesin, Acrylates/ C10-30 Alkyl Acrylate Crosspolymer, Glyceryl Stearate, PEG-100 Stearate, Sodium Hydroxide, Disodium EDTA, Fragrance, Tocopherol, Diethylhexyl Syringylidenemalonate, Aloe Barbadensis Leaf Juice Powder, Sodium Ascorbyl Phosphate, Caprylic/Capric Triglyceride

Principle Display Label

11822-9202-2

daylogic

sunscreen

LOTION

BROAD SPECTRUM SPF 30

UVA/UVB Protection

Water Resistant (80 Minutes)

Vitamin E and Aloe

RECOMMNEDED SKIN CANCER FOUNDATION

ACTIVE

RECOMMENDED AS EFFECTIVE UVA/UVB SUNSCREEN

30

8 FL OZ (236mL)







11822-9202-6

daylogic

sunscreen

LOTION



BROAD SPECTRUM SPF 30

UVA/UVB Protection

Water Resistant (80 Minutes)

Vitamin E and Aloe

RECOMMENDED SKIN CANCER FOUNDATION

ACTIVE

RECOMMENDED AS EFFECTIVE UVA/UVB SUNSCREEN

30

8 FL OZ (236mL)

When Using This Product (When using this product)

keep out of eyes.  Rinse with water to remove.

Stop Use and Ask A Doctor (Stop use and ask a doctor)

if rash occurs

Keep Out of Reach of Children. (Keep out of reach of children.)


If product is swallowed, get medical help or contact a Poison Control Center right away.



  • May stain some fabrics

Advanced Ingredient Data

Raw Label Data

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Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:05.582719 · Updated: 2026-03-14T22:54:18.927073